Microtransplantation in Older Patients With Acute Myeloid Leukemia

Acute Myeloid Leukemia Clinical Trial

Official title:

International Multi-center Clinical Study on Microtransplantation for Treatment of Newly Diagnosed Elderly Acute Myeloid Leukemia (EAML)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02831192
• Other study ID #: EAML-MST
• Status: Completed
• Phase: Phase 2
• First received: July 3, 2016
• Last updated: July 12, 2016
• Start date: May 2006
• Est. completion date: July 2015

Study information

• Verified date: July 2016
• Source: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to see whether HLA-mismatched donor cells infusion with chemotherapy (microtransplantation，MST) could increase complete remission (CR) and improve survival in older patients with acute myeloid leukemia (AML)，the investigators conducted a prospective, multicenter clinical trial of HLA-mismatched MST to estimate outcomes and toxicities.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 90 Years

Eligibility

Inclusion Criteria:

• de novo acute myeloid leukemia

• age 60-90

• have HLA mismatched donor

Exclusion Criteria:

• have no suitable donor or donor refused

• patient refused to accept donor cells

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Biological:
• microtransplantation
HLA mismatched donor mobilized prepheral stem cell infusion

Locations

Country	Name	City	State
China	Affiliated Hospital of Academy of Military Medical Sciences ,	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Graft versus host disease		1 month	Yes
Secondary	overall survival		2 years	No
Secondary	leukemia free survival		2 years	No
Secondary	complete remission rate		2 months	No